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Powdered Baby Formula Tragedy

Posted by: " Birth " birth@... gloria_lemay

Thu Nov 20, 2008 8:30 am (PST)

See video at:

<http://cbs2chicago.com/video/?id=51358wbbm (DOT) dayport.com & cid=48>

http://cbs2chicago.com/video/?id=51358wbbm (DOT) dayport.com & cid=48

Nov 13, 2008 9:16 pm US/Central

2 Investigators: Formula For Tragedy

Powdered Baby Formula Could Be Dangerous For Some Infants

Dave Savini

CHICAGO (CBS) ¯ A warning for parents: Milk-based powdered formula

could put premature babies at risk.

And it is a possible cause for the death of an infant born at Rush-

Copley Medical Center in Aurora and other babies across the country.

Connor McGray and his twin brother, Logan, were born prematurely on

Nov. 16, 2007, at Rush-Copley.

Connor appeared to be the healthier of the two - until a week later

when their parents, Carlin and Tim McGray of Somonauk,

received

a call from a doctor at the hospital, saying the infant was lethargic

and refusing to eat.

Doctors discovered Connor had meningitis, McGray said, and " they

basically told us, all we could do (was) pray. "

The baby died at home on May 3, 2008, five months after he was born.

The cause of death listed on the baby's death certificate is

hydrocephalus and bacterial meningitis. The bacterial infection,

according to a memo from the Illinois Department of Public Health,

" may be associated with the consumption of a powdered breast milk

fortifier. "

The Enfamil brand powdered formula was fed to the baby while he was

being cared for in the Neo-Natal Intensive Care Unit at Rush-Copley.

In a statement released Thursday, Rush-Copley said, " We have the

utmost compassion for the baby and his family.

" Rush-Copley delivers 4,000 babies a year and the procedures followed

here are consistent with the standards of care provided to

prematurely

born infants in the U.S. "

The danger with powdered formula is that, unlike the liquid kind, it

cannot be sterilized, making it vulnerable to bacteria growing in it,

according to the Centers for Disease Control and Prevention.

The most severe cases involve babies exposed to a bacteria called

Enterobacter sakazakii, or E-sak, which can lead to raging

infections,

severe brain damage, and ultimately death, according to the CDC.

Carlin said son Connor died after the E-sak bacteria led to an

infection which caused the deadly form of meningitis.

The baby suffered from seizures and brain abscess. And his blood and

cerebral spinal fluid tested positive for the organism, the Health

Department document says.

During the week before Connor's illness, the Health Department memo

says, he was fed ready-to-feed liquid formula as well as breast milk

with powdered infant fortifier.

The powdered formula used by the hospital was Enfamil by Mead

.

Connor consumed the product from Nov. 20 through Nov. 24 orally and

through a nasogastric tube, the Health Department says. The report

said the product was prepared at the hospital in a prep area/station,

not a dedicated formula preparation room.

On Dec. 3, 2007, Connor was transferred from Rush-Copley to the

University of Chicago because, McGray said, the family wanted the

twin

boys together. Logan was being treated at the University of Chicago

for an intestinal condition.

Infants born prematurely, or those with weak immune systems, are at

greatest risk of being infected, according to the U.S. Department of

Health and Human Services. There is even a warning on powdered

formula

containers. One brand warns: " ... powdered infant formulas are not

sterile and should not be fed to premature infants or infants who

might have immune problems unless directed and supervised by your

baby's doctor. "

Carlin said the hospital did not tell her about the risks of powdered

formula. She said she also didn't learn about her son being given the

powder, until she hired The Law firm in Naperville.

" We didn't find out until afterward, when we got a hold of whatever

medical records we could get, " McGray said. " That's the only way we

knew. "

A CBS2/Beacon News investigation uncovered other cases in which

powdered formula was blamed for causing brain damage or death in

infants. There have been at least two Illinois cases, and cases in at

least 17 other states.

" It's not an isolated problem, " said Ed Manzke, one of the attorneys

hired in Connor McGray's case. " There have been deaths all across the

country related to powder infant formulas. And what is so shocking

about it, is hardly anyone knows it. "

A 2001 E-Sak outbreak in Tennessee led to a 2002 U.S. Food and Drug

Administration warning to health professionals. In a letter the FDA

wrote: " .. FDA recommends that powdered infant formulas not be used

in

neonatal intensive care settings unless there is no alternative

available. "

The FDA also said there are sterilized liquid fortifiers on the

market

that can be used as an alternative. The FDA would not put a complete

ban on the powder and said it may be used in the NICU when no

appropriate liquid product is available.

Five years after this FDA warning, Connor McGray was given the

powdered formula, according to the Health Department document.

His family says he was getting stronger and doing well until he got

the powder.

Similar to Connor, Korte was born prematurely last year. He,

too, was fed powdered infant formula and was struck with the same

infection and meningitis. His parents said the contaminated formula

was fed to him at Mercy Medical Center in Des Moines, Iowa.

survived, but is living in a nursing facility on a ventilator.

" It basically turned his brain to mush, " said Korte,

's

mother. " He is ventilated and his upper brain is destroyed. "

Korte said the hospital in this case also never warned her about the

risk associated with the formula. An attorney she hired, Andy

Weisbecker, said powdered formula manufacturers need to do a better

job of informing doctors and parents about the danger.

" More needs to be done to increase the level of knowledge about this

deadly bug, " Weisbecker said. " Who knows how many parents are out

there with affected children who may still not be aware of a possible

connection between these illnesses and contaminated formula. "

Federal regulators believe the number of cases are under-reported.

There may be other infants diagnosed with meningitis that have not

been checked for E-sak.

Babies are not just being sickened by formula in hospitals, however.

Parents unknowingly are buying the powdered formula for at-risk

babies.

Meyer, an attorney at the Law Office of Nick Stein in

Indiana,

has spent nine years working on E-sak cases. He said the FDA's

warning

should have gone to consumers.

" Most moms would think 'If it's marketed to me, it's safe,' " said

Meyers. " Especially if it comes in a hospital gift bag. "

Mead , manufacturer of powdered formula including Enfamil,

said

its products are safe as long as they are used according to label

directions. The company said it has " taken the position that powdered

infant formula should not be used in neonatal intensive care settings

unless no alternative is available. "

Tracey Noe, a spokesman for Abbott, which manufactures formula

including Similac, said it uses rigorous testing procedures,

including

bacterial testing, on its powdered formulas.

" Abbott agrees with the U.S. Food and Drug Administration/Centers for

Disease Control and Prevention joint recommendation that powdered

formula should not be used in hospital neonatal intensive care units

- unless no nutritionally suitable alternative is available, " Noe

said.

Both manufacturers have been sued by formula victims.

The parents of Connor McGray and Korte are also planning to

file lawsuits. In the meantime they are talking about what happened

in

hopes of warning - and educating - doctors, hospital staff and

other parents about the potential danger of powdered formula.

" I want other people to be aware of it so they don't have to go

through what I did, " Carlin said.

Moyer of the Aurora Beacon News and Michele Youngerman and

Diotallevi of CBS2 contributed to this report.

<http://cbs2chicago.com/local/baby.formula.tainted.2.863980.html>

http://cbs2chicago.com/local/baby.formula.tainted.2.863980.html

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